Lyu, Jian http://orcid.org/0000-0001-6518-622X
Xie, Yan-ming
Gao, Zhan
Shen, Jian-wu
Deng, Yue-yi
Xiang, Song-tao
Gao, Wen-xi
Zeng, Wen-tong
Zhang, Chun-he
Yi, Dan-hui
Wang, Lian-xin
Wang, Zhi-fei
Funding for this research was provided by:
the China International Food and Medicine Exchange Center of NMPA Commissioned Research Project “International Publicity on the Safety of Traditional Chinese Medicine” (Z0531)
Fundamental Research Funds for the Central Public Welfare Research Institutes (Z0546)
Scientific Research Innovation Team Project of China Academy of Chinese Medical Sciences (PY1303)
Research Project of Postgraduate Education and Teaching Reform of China Academy of Chinese Medical Sciences (JG201703)
Article History
Received: 4 December 2018
Accepted: 26 June 2019
First Online: 19 July 2019
Ethics approval and consent to participate
: The protocol has been approved by the Ethics Committee of the XiYuan Hospital, China Academy of Chinese Medical Sciences (2018XLA03l-3), the Longhua Hospital Shanghai University of Traditional Chinese Medicine (2018LCSY034), the Guangdong Provincial Hospital of Traditional Chinese Medicine (BF2018–083-01), the Hubei Hospital of Traditional Chinese Medicine (SL2018-C19–01), the Affiliated hospital of Chengdu University of Traditional Chinese Medicine (2018KL-053), the Yunnan Provincial Hospital of Traditional Chinese Medicine (2018LLZ-014-NO.01). Based on the Declaration of Helsinki, written informed consent will be obtained from all study participants. Any modifications to the protocol that may impact the conduct of the study, the potential benefits to the patients, or patient safety will require a formal amendment to the protocol, which should be approved by the ethics committee prior to implementation. Protocol modifications will be communicated to all centers involved through regular meetings and telephone conversations. All staff will be notified, trained, and qualified before conducting the trial.All patient-related information including case reports, laboratory specimens, and evaluation forms will be kept strictly confidential. All records will be kept in a safe, locked place and secured with password-protected access systems. To protect confidentiality, identification information will be deleted from all study documents.
: Written informed consent will be taken from all participants before their taking part in the study.
: The authors declare that they have no competing interests.